AX-2025-020063 · P21 · SWB lot SWB-2408-T8372

Section 1

Results

Measured against the index acceptance specification for the neuroactive and cognitive peptides class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 15 min gradient, 214 nm	99.02	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.98	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — aspartimide (−18 Da)	0.55	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	805.3970	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	805.4005	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+4.3	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	84.78	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	83.95	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.87	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.928	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	98.6	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	8.23	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	6.79	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.20	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
Appearance	visual, diffuse light, black and white background	White lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Clear after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.90	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	5.64	min	5.63 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.11	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	60,037	—	≥ 20,000	PASS
Resolution to nearest impurity	vs free acid (+1 Da)	1.17	—	no index criterion	REPORTED

Section 2

Chromatogram and peak integration

The figure is drawn from the table. It is not an independent illustration — if a number in the table changed, the trace would change with it.

Figure 1. RP-HPLC trace, 15 min gradient, 214 nm. Drawn from the peak-integration table below: peak positions are the reported retention times, peak areas are the reported area percentages, peak widths follow the reported plate count of 60,037, and skew follows the reported asymmetry factor of 1.11. Baseline noise is seeded from the report ID and is illustrative. The lower panel is the same trace at a stated vertical expansion with the slow gradient drift subtracted, because at full scale a 0.55 % impurity against a 99.02 % main peak is a line two pixels tall; the main peak runs off-scale there by design.

#	Peak	RT	Area (µV·s)	% area	Δ mass (Da)
1	P21 — main peak	5.64	4,812,679	99.02	—
2	aspartimide (−18 Da)	5.79	26,732	0.55	-18.011
3	des-adamantyl (−134 Da)	4.61	14,095	0.29	-134.110
4	des-acetyl (−42 Da)	5.43	3,888	0.08	-42.011
5	free acid (+1 Da)	5.75	2,916	0.06	+0.984
Closure check — purity + Σ impurities				100.00	CLOSES

Reporting threshold 0.05 % area. Peaks below it are not reported and are therefore excluded from the total, which overstates purity by their sum — see peak integration.

Section 3

Mass spectrum and identity

Theoretical monoisotopic mass 805.3970 Da, computed from C36H55N9O12. All ppm figures on this site are against monoisotopic values — see why that matters.

Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 805.4005 Da. Sodium (+21.982/z) and potassium (+37.956/z) adducts are shown where the parent charge state exceeds 25 % relative abundance; they are adducts of the same molecule and are not impurities.

Charge	Theoretical m/z	Observed m/z	Δ m/z	Rel. abundance (%)
2+	403.7058	403.7075	0.0017	55.6
1+	806.4043	806.4078	0.0035	100.0

Section 4

Gravimetric mass balance

Water, counter-ion, residual and total peptide content are exhaustive and mutually exclusive categories. They must account for 100 % of the cake mass. The index closes this to within 0.02 pp and the build asserts it.

Component	Determination	%w/w of cake
Water	Karl Fischer	8.23
Counter-ion (acetate)	ion chromatography	6.79
Residual solvent + inorganic residue	estimated	0.20
Total peptide content	by difference	84.78
Total		100.00 CLOSES

Supplier certificate, as declared

The supplier's own figures for this lot, beside the independent measurement. Divergence is assessed against the batch median, not against this single report — see rule AX-R05.

Figure	Supplier COA	This report	Index note
Purity (% area)	99.22	99.02	divergence -0.02 pp vs batch median
Total impurities (% area)	0.78	0.98
Largest single impurity (% area)	0.51	0.55
Water (%)	not stated	8.23
Counter-ion (%)	not stated	6.79
Peptide content (%w/w)	not stated	84.78
Endotoxin (EU/mg)	not stated	not determined
Method stated on certificate	YES	—	column, gradient and wavelength given

Section 5

Provenance and caveats

Where a sample came from changes the weight of the evidence. The index treats it as a first-class field.

Sample provenance: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Domestic warehouse despatch → submitter (2–8 °C, 3 d) → laboratory (courier, cold pack, 4 d) → assay.
Assay date: 26 Mar 2025
Submitted to the index: 11 Apr 2025
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
That the material is free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
That the material is sterile. Sterility was not tested.
That any other vial in the same lot has the same composition. One vial was tested. Within-lot vial-to-vial variation in this index has a median of 0.28 pp and a 90th percentile of 0.74 pp.
That any other lot from the same supplier has the same composition. Batch-to-batch variation is larger than within-batch variation for every supplier here.
That the material is suitable for administration to a human or an animal. These are research compounds. No result on this site is a safety assessment and the index takes no position on use.
That the material was manufactured by the supplier that sold it. Contract synthesis is normal in this market and twenty-nine batches in the index fingerprint to a bulk from a different company than the one named on the label.

Section 6

Annotations 2

Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.

ppm_error11 Apr 2025

Instrument was evidently in calibration on the day. A run of results at this accuracy across a laboratory's sequence is the background against which an excursion becomes interpretable.

buyer_sourced11 Apr 2025

Independently purchased, at the submitter's own cost, forwarded without the supplier's involvement. That is the definition and this record meets it.

Section 7

Related records

Same batch — lot SWB-2408-T8372 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-020062	SWB-2408-T8372	Janoshik	2025-Q1	99.22	8.28	90.7	Buyer-sourced	PASS
AX-2025-020064	SWB-2408-T8372	Janoshik	2025-Q1	99.25	8.45	—	Buyer-sourced	PASS
AX-2025-020065	SWB-2408-T8372	Janoshik	2025-Q1	99.74	8.56	98.6	Buyer-sourced	PASS
AX-2025-020066	SWB-2408-T8372	Janoshik	2025-Q1	98.76	7.35	94.7	Buyer-sourced	PASS
AX-2025-020067	SWB-2408-T8372	VendorInvestigate	2025-Q1	99.05	8.58	106.1	Buyer-sourced	PASS
AX-2025-020068	SWB-2408-T8372	Nordanalyt	2025-Q1	99.52	8.16	—	Buyer-sourced	PASS
AX-2025-020069	SWB-2408-T8372	Medutest	2025-Q1	99.40	8.62	103.6	Buyer-sourced	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent P21 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-020065	SWB	SWB-2408-T8372	Janoshik	2025-Q1	99.74	8.56	98.6	Buyer-sourced	PASS
AX-2025-020069	SWB	SWB-2408-T8372	Medutest	2025-Q1	99.40	8.62	103.6	Buyer-sourced	PASS
AX-2025-020066	SWB	SWB-2408-T8372	Janoshik	2025-Q1	98.76	7.35	94.7	Buyer-sourced	PASS
AX-2025-020067	SWB	SWB-2408-T8372	VendorInvestigate	2025-Q1	99.05	8.58	106.1	Buyer-sourced	PASS
AX-2025-020068	SWB	SWB-2408-T8372	Nordanalyt	2025-Q1	99.52	8.16	—	Buyer-sourced	PASS
AX-2025-020062	SWB	SWB-2408-T8372	Janoshik	2025-Q1	99.22	8.28	90.7	Buyer-sourced	PASS
AX-2025-020064	SWB	SWB-2408-T8372	Janoshik	2025-Q1	99.25	8.45	—	Buyer-sourced	PASS

Other recent SWB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042637	Semaglutide	SWB-2602-X7905	Janoshik	2026-Q3	98.37	4.26	102.9	Buyer-sourced	PASS
AX-2026-042645	Semaglutide	SWB-2602-X7905	Medutest	2026-Q3	98.48	4.52	95.2	Buyer-sourced	PASS
AX-2026-042642	Semaglutide	SWB-2602-X7905	PeptideMeter	2026-Q3	97.96	4.48	90.8	Buyer-sourced	PASS
AX-2026-042640	Semaglutide	SWB-2602-X7905	PeptideMeter	2026-Q3	98.55	4.29	—	Buyer-sourced	PASS
AX-2026-042638	Semaglutide	SWB-2602-X7905	Janoshik	2026-Q3	98.74	3.65	—	Buyer-sourced	PASS
AX-2026-042639	Semaglutide	SWB-2602-X7905	Janoshik	2026-Q3	98.77	4.21	—	Supplier-supplied	PASS
AX-2026-042641	Semaglutide	SWB-2602-X7905	Janoshik	2026-Q3	98.86	4.48	99.1	Buyer-sourced	PASS
AX-2026-042644	Semaglutide	SWB-2602-X7905	PeptideMeter	2026-Q3	98.76	3.57	97.7	Buyer-sourced	PASS